中国药企出海报告(英).docx

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1、NAVIGATINGG1.OBA1.MARKETSCO-PRODUCEDBYPharmcubeiDeal三命PHARMCUBEEmpowerBiopharmaInnovationAccelerateDecision-makingFoundedin2015,Pharmcubestrivestoreconstructpharmaceuticaldata,bridgetheinformationgap,andthoroughlyempowerinnovation.Byleveragingdataacrossthefulllife-cycleofpharmaceuticalproductsplussc

2、alableandhighlycompatibleAltechnology,Pharmcubehassuccessfullylaunchedovertenenterprise-leveldataproducts,serving1,000+leadingpharmaceuticalcompaniesandinvestmentinstitutions.Wealsoprovideyouwithmediaandconsultingservicesthatfacilitateyourstrategicplanninganddecision-makingandpromotetheinnovationand

3、transformationofthepharmaceuticalindustry.OurIndustryInfluenceOurtrustworthydataandconstantly-improvingservicehavewonclient,sheart.800,000+Millionsof1000+7years1.eadingpharma.AccumuUttionoSubscriboraSearchespermonthcompaniesandinstitutions,choicepharmaceuticaldataWeAreGrowingWeteamupwithtoptalents.O

4、ver56%masterorPh.Dholders,andmorethan60%topuniversitygraduates(suchasPekingUniversity,TsinghuaUniversity,FudanUniversityorShanghaiJiaoTongUniversity),around10%ofthemreceiveeducationinoverseasuniversities.Ourteamofdataspecialistshavenotjustexperiencebutalsothespirittoinnovate.PharmcubeNeXtBiOPharmTM-

5、Timely,accurateandreliableintelligenceonglobalnewdrugsIntroducingNextBiopharm,acutting-edgedatabasemeticulouslycraftedandlaunchedbyPharmcube,designedspecificallytospotlightglobalnewdrugswithunparalleledcoverageintheChinesemarket.Thisplatformseamlesslyintegratesandstandardizesawealthofinformation,inc

6、ludingpatents,literature,clinicaltrials,news,deals,andmarketingdata,providingacomprehensiveoverviewofeverynovelmoleculeworldwide.AsaproudmemberofthePharmcubefamily,NeXtBiOPharmTMTMiswelllinkedwithotherofferingssuchasNextPat,PharmaGO,MedAlpha,etc.,ensuringarobustconnectivitythatcaterstothediverseneed

7、softhepharmaceuticalMini-programClinicalDataKnowledgeCardsNewsandRePOrtSTranslationalScienceCompetitiveIntelligenceDiseaseAnalysisBusinessAnalysisdrugsAnalysisTargetA呵ysisAlCapabilities:Automatedprediction/Auto-FlownnntafinnHumanIntelligence:InsightfulAnalysisDatamonitoringCleansingMndardizationindu

8、stryandinvestorsalike.WebDal三三iDealsVDREmpowers75%ofOut-licensingDealsAsBDtransactionsbecomemorefrequentandactive,iDealsSolutionsprovidesacomprehensiveVDRsolution,whichisasapowerfulassistantforBDtransactionsinthebiopharmaceuticalindustry:thevirtualdataroom(VDR)becomesanindispensabletoolforinformatio

9、ninteractionatatimewhendistancesmakeinformationinteractioninconvenientandtheprocessofbuildingtrustverylengthy.Itsimplifiestheprocessofsharingandmanagingsensitiveandconfidentialdocuments.Itsfinancial-gradedocumentsecuritysolutionensuresthatthecompanysconfidentialdocumentsmeetthemoststringentcomplianc

10、erequirementsinBDtransactionusagescenarios.EmpowerstheentireprocessofcorporateBDtransactions,includingprotectingdatasecurity,supportingduediligenceandauditing,enhancingtransactionefficiency,improvingtransactiontransparency,andreflectinganefficientprofessionalimage.ContactUsPharmcubeContactus:AboutPr

11、oduct/ServicedaisiweiAfter-SalessanyunanForMediaCollaborationzhangxiaoyiiDealsContactus:Trialrequest:iohn.vuaridealscogcomWWWCONTENTSPARTONEFollowthetrendofthetimesFactorscompellingChinesepharmaceuticalcompaniestogoglobal7PARTTWOInsightsontransactionsScenariosanddataofChinesepharmaceuticalcompaniesg

12、oingoverseas18PARTTHREEEarlymoversIn-depthanalysisoftypicalcases24PARTFOURData-baseddecision-makingApplicationofdatainscreeningoverseasopportunities41PARTONEFactorsCompellingChinesePharmaceuticalCompaniestoGoGlobalIInrecentyears,Chinesepharmaceuticalcompanieshavebeentakingtheinitiativetotapintothegl

13、obalmarketasaresultofanumberoffactors.lntensecompetitionwithintheChinesemarketisdrivingcompaniestoseekoutopportunitiesforsurvivalspaceinoverseasmarkets.Themedicalinsurancepaymentreformandrestrictedhospitalaccesshavesqueezedtheprofitmarginsofinnovativedrugs.Additionally,somesectorswithintheindustryha

14、vewitnessedfiercecompetitionsurroundinghomogeneousproducts.Consequently,someChinesecompaniesareturningtotheglobalmarketfornewgrowthspaceandstrongerprofitability.IFacedwithfinancialchallenges,manycompaniesarechoosingtoseekinvestmentandcollaboratewithothersinordertostayinbusiness.Thepharmaceuticalindu

15、stryisexperiencingdownwardpressure,withmostcompanieshavingdifficultyinfundingandcashflows.Inlightofthis,relinquishingaportionoftheirinterestsintheoverseasmarketinreturnforcashandsubsequentfundingpresentsanadvantageoussurvivalstrategyformostcompanies.IWithgrowingstrengthinR&Dofnewdrugs,Chinesecompani

16、esshowstrongerglobalcompetitiveness.AsmoretalentsreturntotheChinesemarketandinnovationfactorsaccumulate,China-originatedbiotechsaresteppingintotheglobalspotlight,whichisattributedtogreatlyimprovedcapabilitiesinnewdrugsR&Dandoutstandingpotentialinrapidtargettranslationandbest-in-class(BIC)/first-in-c

17、lass(FIC)R&D.(GovernmentpoliciesencourageChinesecompaniestoacceleratetheirquestforinternationaldevelopment.Source:ResearchandanalysisbyPharmcubeChinaspharmaceuticalindustryhasenteredanewstageofdevelopment.Inrecentyears,nationalregulatorypolicieshavealignedwithinternationalstandardsandencouragedChine

18、secompaniestoexploreoverseasmarkets,inordertospeedupinnovation-drivendevelopmentandallowforbetterintegrationintotheglobalindustrialsystem.ThenumberofInvestigationalNewDrugApplicationversusinternationalexpansioneventsbyChinesepharmaceuticalcompaniesinrecentyearsNumberofnewdrugsgooverseasbyChinesephar

19、maceuticalmpaniesNumberofINDfornewdrugsbyChinesepharmaceuticalcompaniesInrecentyears,Chinesepharmaceuticalcompanieshavebeentakingtheinitiativetotapintotheglobalmarketasaresultofnumerousfactors.Inrecentyears,ChinesecompanieshaveexhibitedagreatercapabilityinR&Dofinnovativedrugs.Thenumberofinvestigatio

20、nalnewdrugs(IND)hasnoticeablyrisen,resultinginanincreasednumberofnewdrugsbeingexportedoverseas.Chinaranksthesecondintheworld,aftertheU.S.,intermsoftheChinaUKJapanGermany201817171113121088889475O5032224520152016201720182019202020212022numberofmilestonepublications,surpassingGermany,theUK,andJapan.Int

21、hisrespect,Chinesepharmaceuticalcompaniesareclosingthe300296261ChinaU.S.216I204249238244243227215200116490130176132IOd52114gapwiththeircounterpartsintheU.S.,showingannually192532enhancedcapabilityinR&Dofinnovativedrugs.o:2014201520162017201820192020202120222023Thehistoricalnumberofbreakthroughtransl

22、ationalmedicalresearchesinChina,Japan,andEuropeNote:Breakthroughtranslationalmedicalresearchreferstomilestonepapersinthefield.NumberofpivotalclinicaltrialsconductedbypharmaceuticalcompaniesinChinaandtheU.S.inthelastdecadeSource:ResearchandanalysisbyPharmcube;NextBiopharmdatabase;dataasofJuly25,2023.

23、GovernmentpoliciessupportChinesepharmaceuticalcompaniesinaccessingoverseasmarketsandexpandingintointernationallyrecognizedbrands.Beginning:InitialexplorationoftheglobalmarketIn1990,regulatoryauthoritiesandinternationalassociationsintheEU,U.S.,andJapancreatedtheInternationalCouncilforHarmonisationofT

24、echnicalRequirementsforPharmaceuticalsforHumanUse(ICH)toenhancethetechnicalrequirementsfordrugsregistrationviaharmonization.InJune2017,theformerChinaFoodanddrugsAdministration(CFDA)joinedICH5markingtheofficialstartofChinasinternationaljourneyinpharmaceuticalregulationanddevelopment.GuidingChinesecom

25、paniestoalignwithinternationalstandardsinthedesignofclinicalresearchandthedevelopmentofnewdrugsAdoptingthetowidelyrecognizedCTDformattodiminishrepetitiveworkandlowercostforcompaniesandenhancetheirsuccessininternationalregistrationAcceptingoverseasclinicaltrialdata,thuspushingChinesecompaniestobolste

26、rtheirR&DcapacityandqualityofdrugproductsremaincompetitiveINumberofMRCTclinicaltrialsconductedbyChinesecompanies2012-20162017-2021NumberofMRCTconductedbyChinesepharmaceuticalcompaniesbeforeandafterChinajoinedICHoverafive-yearperiod.Developing:Proactivedevelopmenttowardsinternationallyrecognizedbrand

27、sCentral1.ocalInDecember,2021,sixgovernmentdepartmentsjointlyreleasedtheNoticeontheDevelopmentofthePharmaceuticalIndustryduringthe14thFive-YearPeriodDuringthe13thFive-YearPlan(FYP)period,Chinaspharmaceuticalindustryunderwentagradualshifttowardshigheraddedvalue.Duringthe14thFYPperiod,aprimaryobjectiv

28、eforChinesecompaniesistoemergeasworld-classpharmaceuticalcompanies.Moreover,the14thFYPhashighlightedthesignificanceofupholdingopennessandcooperation,strivingtoexploretheglobalmarket,participatingininternationalindustrialdistributionandcollaborationatahigherlevel.Since2019,eightbiomedicineindustrialb

29、aseshaveissuedpoliciestobolsterindustryprogress.ExpandingtheglobalpresencehasbeenakeyfocusofChinaspoliciesinsupportingthedevelopmentofthepharmaceuticalindustry.ShenzhenofferedaqrantofuptoRMB同Eightcitiesofferaproportionalgrantto5millionforproductsverifiedbytheAwardingsuccessfulapplicationsproductsapp

30、rovedbygloballyrecognizedinstitutionsforthefirsttime.UnitedStatesFoodanddrugsAdministration(FDA)ortheEuropeandrugsAgency(EMA)(theexactamountwasdeterminedbyinvolvingprofessionalauditingcompanies).CoverageContentExamplesFacilitatingcustomclearanceFourcitiesofferadvantageousconditionsandsupportforcontr

31、olleditemstoenhanceR&Dandimprovesupplychain.ooSupportingcooperationTwocitiesfacilitateChinesecompaniesinengaginginbusinesspartnershipswithmultinationalcompanies.ShanghaifacilitatedthecustomsclearanceofR&Dmaterialsandspecificspecialitems.Italsostrengthenedsecurityregulationsthroughapilotedjointregula

32、tionfortheexitandentryofspecialitemsattheborder.BeijingsupportedChinesecompaniesspecializingininnovativedrugstoauthorizemultinationalcompaniesfortechnologicalresearchandestablishcommercialpartnershipsforproductdevelopment.ItprovidedagranttoChinesecompanies,amountingto20%oftheupfrontpaymentforeachpro

33、duct,withamaximumcapofRMB5million.1.TheeightmajorbiomedicineindustrialbasesinChinaincludeBeijing,Shanghai,Suzhou,Hangzhou,Chengdu,Wuhan,Guangzhou,andShenzhen.Source:ResearchandanalysisbyPharmcube;Governmentwebsites.PharmaceuticalcompaniesencounterdevelopmentobstaclesintheChinesemarket,primarilyconsi

34、stingofacaponmedicalinsurancepricingandlimitedhospitalaccessibility.MedicalinsuranceIttakesyearsforanewlylauncheddrugstobeincludedinmedicalinsurancethroughnegotiation.Theaveragetimeforanewlyapproveddrugstobecoveredbyhealthinsuranceisdecreasingeachyear.10yrs6-10yrsH3-5yrs0-2yrsPricereductionasaresult

35、ofmedicalinsurancenegotiation.Medicalinsurancenegotiationshaveappliedsignificantpressureonthereductionofprices.Source:ResearchandanalysisbyPharmcube;PharmaGodatabase;dataasofJuly2023.MaximumreductionAveragereductionHospitalaccessibility142NewdrugsallowedforuseinpublicmedicalinstitutionsinBeijingwith

36、inthepastfiveyearsNumberofhospitalsTier3hospitalsTier2hospitalsTier1hospitalsOthersHospitalcoveragerateCoveragerate.OthersTier3hospitalsTier2hospitalsTier1hospitalsOthersNumberofgradedhospitalsNumberofnewdrugsallowedintogradedhospitalsinBeijingfrom2019to2023Source:ResearchandanalysisbyPharmcube;Phar

37、maGodatabase;dataasofJuly2023.Underthedualpressureofproductpricinganddomesticcompetition,Chinesepharmaceuticalcompaniesareseekingtoexpandtheirgrowthhorizonsandtomakebreakthroughsbyturningtooverseasmarkets.AnnualexpenditurefortreatmentwithPD1productsinChinaandtheU.S.1Differentproceduresforaccessingho

38、spitalsinChinaandtheU.S.1AvailabilityandAffordabilityofOncologydrugsin2012-2021inChinaandtheUnitedStatesSource:ResearchandanalysisbyPharmcube;Companyannualreports;Deskresearchmaterials.ChinaandtheU.S.havecontrastingproceduresforauthorizingaccessofnewdrugstohospitals.TheChineseproceduresarecomplexand

39、time-consuming,whilethethree-partymodelintheU.S.makesiteasierforcompanies.ChinaThedepartmentofhospitalsubmitsclinicaltrialapplicationDrugManagementCommitteereviewstheapplicationSelectionofsuppliersPrurementofdrugsMedicalU.S.institutionsCommercialinsuranceThird-partyUnlikeintheU.S.wheredrugsarepriced

40、basedontheirvalue,drugsinChinaaregenerallypricedbasedontheircost,resultinginlowerpricesandsignificantlysqueezedprofitforpharmaceuticalcompanies.Globalpharmaceuticalmarketsizeandpopulationstructurein2021-2025ESource:ResearchandanalysisbyPharmcube;companyannualreports;deskresearchmaterials.49%11%I39%5

41、0%15,63111%38%51%16,41211%)52%17,233:Tl%37%53%Pharmaceuticalmarketsize(in100millionUSD)202178%4%唾78202278%4%睡802023E78%4%曜812024E79%4%瞪812025E79%4%瞪82ChinaHU.S.OthersPopulation(100millionpeople)Theglobalmarkettakesprecedenceoverallothermarkets.Thus,itisimperativeforChinesepharmaceuticalcompaniestopr

42、oactivelyexploretheoverseasmarketinordertomakeanameforthemselvesintheworld.SalesofBeiGene1SZanubrutinibinrecentyearsTheoverseasmarkethasbecomethemainsourceofsalesforZanubrutinib5withasignificantlyhighergrowthratethantheChinesemarket.Fundinghasbecomeincreasinglytoughinrecentyears,somostpharmaceutical

43、companiesarelookingtoimprovecashflowandsecurefundingthroughtransactionsandcollaborations.FundinginChinesemarketinthepastdecadeIn2020,thepharmaceuticalindustrybegantoexperiencefundingchallenge.Chinesecompaniesfounditincreasinglydifficulttofinancingandmaintainhealthycashflow.Amountoffunding,in100milli

44、on.No.offundingcasesSource:ResearchandanalysisbyPharmcube;NextPharmadatabase;MedAIphadatabase;dataasofAugust15,2023.UpfrontpaymentsreceivedbyChinesepharmaceuticalcompaniesin20201to2022Tosomeextent,transactionshaveassistedtheIincensorsinsecuringadditionalfunding.20142015201620172018201920202021202220

45、23ThesetransactionshavebroughtsomecashflowtoChinesecompanies.0.25650mUSDAmountofupfrontapayment1%68%ProportionofupfrontpaymentIncertaintransactions,thelicenseehasmadeinvestmentsUUbeforeorafterthetransaction(on-exhaustivelist).Transaction.11.icensor1.icenseeInvestmentdateInJune2021,1.illyAsianRegorDec10,2021TherapeuticsEli1.JlIyVenturesledtheseriesBfinancinginRegorTherapeutics.JhSOInJUne2022,Joson&DACJohnsonInnovationledaJune1,2022Biotechnology&strategicinvestmentinDACJohnsonBiotechnology.Successfultransactionsenhancetheconfidenceofotherinvestors.命PharmcubeiDeal三17PART

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